Proven efficacy in patients with advanced cutaneous squamous cell carcinoma (CSCC)1

Response rates in patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation (N = 108), based on combined analysis of Studies 1423 and 15401

  • aPartial response is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. Partial response of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest dimensions of target lesions, per WHO Criteria. Responses had to be maintained for at least 4 weeks.2
  • bComplete response is defined as disappearance of all target lesions for at least 4 weeks. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1,2
  • RECIST, Response Evaluation Criteria in Solid Tumors; WHO, World Health Organization.

Considerable tumor reduction with LIBTAYO1

Tumor responses demonstrated with LIBTAYO in patients with metastatic CSCC or locally advanced CSCC who were not candidates for curative surgery or curative radiation, based on combined analysis of Studies 1423 and 15401,a,b

Efficacy endpoints Metastatic
(n = 75), %
Locally advanced
(n = 33), %
Combined
(N = 108), %
Complete response, CRc 5.3 0 3.7
Partial response, PRd 41.3 48.5 43.5
Objective response rate,
ORR (CR + PR)
46.7 48.5 47.2
  • aResults as of data cutoff. Group 2 patients (laCSCC; cemiplimab-rwlc 3 mg/kg Q2W) who started treatment less than 9 months prior to the data cutoff date and all Group 3 patients (mCSCC; cemiplimab-rwlc 350 mg Q3W) from Study 1540 are excluded from the efficacy analysis set.2
  • bAt time of data cutoff, median duration of follow-up was 8.1 months for mCSCC, 10.2 months for laCSCC, and 8.9 months for combined CSCC.1
  • cComplete response is defined as disappearance of all target lesions for at least 4 weeks. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; locally advanced CSCC patients in Study 1540 required biopsy to confirm CR.1,2
  • dPartial response is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. Partial response of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest dimensions of target lesions, per WHO Criteria. Responses had to be maintained for at least 4 weeks.2
  • laCSCC, locally advanced cutaneous squamous cell carcinoma; mCSCC, metastatic cutaneous squamous cell carcinoma; Q2W, every 2 weeks; Q3W, every 3 weeks.
NCCN preferred Category 2A Option for Advanced CSCC
NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®)

Category 2A* (Preferred) Recommended Systemic Therapy Option for Patients With Advanced Cutaneous Squamous Cell Carcinoma If Curative Surgery and Curative Radiation Therapy Are Not Feasible3

NCCN Guidelines® recommend cemiplimab-rwlc (LIBTAYO), an immune checkpoint inhibitor, as the only preferred systemic therapy option for appropriate patients with3:

  • Locally advanced or regional CSCC when curative surgery and curative radiation therapy are not feasible
  • Distant metastatic or regionally recurrent CSCC when curative surgery and curative radiation therapy are not feasible
*Category 2A recommendation is based upon lower-level evidence; there is uniform NCCN consensus that the intervention is appropriate. All recommendations are Category 2A unless otherwise specified.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. To view the most recent and complete version of the guidelines, go online to NCCN.org.

Indication and Usage

LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.

  1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC.
  2. Data on file. Regeneron Pharmaceuticals, Inc.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Squamous Cell Skin Cancer V.1.2020. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed November 10, 2019. To view the most recent and complete version of the guidelines, go online to NCCN.org.